Back to resultsTreatment of Hyperuricemia in Patients With Heart Failure
Primary Purpose
Heart Failure, Hyperuricemia
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Benzbromarone (drug)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Insulin, Metabolism, Pharmacology, Uric Acid
Eligibility Criteria
Inclusion Criteria:
- chronic heart failure
- hyperuricemia
Exclusion Criteria:
- renal dysfunction (Cr > 2.0 mg/dl)
- under treatment with anti-diabetic agents
Sites / Locations
- Tottori University Hospital
Outcomes
Primary Outcome Measures
parameters of echocardiography at 16 weeks
BNP levels at 16 weeks
Secondary Outcome Measures
parameters of glucose metabolism at 16 weeks
Parameters of lipid metabolism at 16 weeks
Full Information
NCT ID
NCT00422318
First Posted
January 12, 2007
Last Updated
January 12, 2007
Sponsor
Tottori University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00422318
Brief Title
Treatment of Hyperuricemia in Patients With Heart Failure
Official Title
Hyperuricemia and the Effects of the Uricosuric Agents Benzbromarone in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tottori University Hospital
4. Oversight
5. Study Description
Brief Summary
The study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.
Detailed Description
Hyperuricemia is often observed in patients with congestive heart failure (CHF). It has been reported that hyperuricemia is related to exercise capacity, inflammation markers and diastolic dysfunction in such patients. In addition, hyperuricemia in CHF relates to both symptomatic status (i.e. morbidity) as well as impaired prognosis (i.e. mortality). Hyperuricemia is likely to play an important role in the pathophysiology of CHF. Up-regulation of xanthine oxidase (XO) activity in CHF has been shown to contribute to higher uric acid (UA) in CHF and the therapeutic concept of XO inhibition has shown beneficial effects in a number of surrogate markers in these patients. The XO inhibition accounts for substantial decrease in oxygen radical load, the latter is discussed as the main benefit of XO inhibition treatment in hyperuricemic patients. However, whether high uric acid itself is important or merely a marker of XO activity (and hence of increased radical accumulation) is currently under discussion. Therefore, this study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Hyperuricemia
Keywords
Heart Failure, Insulin, Metabolism, Pharmacology, Uric Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Benzbromarone (drug)
Primary Outcome Measure Information:
Title
parameters of echocardiography at 16 weeks
Title
BNP levels at 16 weeks
Secondary Outcome Measure Information:
Title
parameters of glucose metabolism at 16 weeks
Title
Parameters of lipid metabolism at 16 weeks
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
chronic heart failure
hyperuricemia
Exclusion Criteria:
renal dysfunction (Cr > 2.0 mg/dl)
under treatment with anti-diabetic agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuhide Ogino, MD
Organizational Affiliation
Tottori University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tottori University Hospital
City
Yonago
ZIP/Postal Code
683-8504
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19933411
Citation
Ogino K, Kato M, Furuse Y, Kinugasa Y, Ishida K, Osaki S, Kinugawa T, Igawa O, Hisatome I, Shigemasa C, Anker SD, Doehner W. Uric acid-lowering treatment with benzbromarone in patients with heart failure: a double-blind placebo-controlled crossover preliminary study. Circ Heart Fail. 2010 Jan;3(1):73-81. doi: 10.1161/CIRCHEARTFAILURE.109.868604. Epub 2009 Nov 20.
Results Reference
derived
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Treatment of Hyperuricemia in Patients With Heart Failure
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